Events

Retiro De Equipo (Recall) de Xpert CT/NG Assay. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Cepheid Holdings Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00375-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-21
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00375-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Reports have been received that some customers have experienced a higher number of invalid results than would typically be expected when using the xpert ct/ng assay and its intended use specimen types. this could lead to the need to retest and consequently, a delay in test results and subsequent treatment.
  • Acción
    Cepheid is advising users to discontinue use and discard affected stock in their inventory. Users are further advised to acknowledge receipt of the recall letter and return it to Cepheid customer service in order to receive replacement stock.

Device

Xpert CT/NG Assay. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Xpert CT/NG Assay. An in vitro diagnostic medical device (IVD)Catalogue Number: GXCT/NG-CE-10Lot Number: 100044234Cartridge Lot Number: 11715Expiration Date: 29 July 2018ARTG Number: 207540
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd